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  3. Certification for Russia, Kazakhstan and EAEU
  4. EAC Declaration for Cosmetics

联系人

Alexej Schmidt
Alexej Schmidt
任事股东
+49 851 226 083 1
alexej.schmidt@schmidt-export.com

EAC certification of cosmetics

Cosmetics, make-up, perfumes and other beauty products subject to EAC Declaration. This means that all products for hair care such as shampoo, conditioner, hair spray or gel, decorative cosmetics such as lipstick, nail polish or mascara, body care like shower gel, bath additive or body lotions, facial care such as creams, masks or peels, deodorants and perfumes need a conformity assessment, before they can be imported into Russia, Kazakhstan or the EAEU.

Legal framework

The products must demonstrate their conformity with the technical regulations of the Eurasian Economic Union. The technical regulation TR CU 009/2011 On safety of perfume and toiletrie products consists of special requirements for the cosmetics.

According to the technical regulation TR CU 009/2011 there are 2 forms of conformity assessment: EAC Declaration and state registration.

EAC Declaration

The EAC declaration is a manufacturer's declaration that the products meet the minimum requirements of the technical regulation of the Eurasian Economic Union. The declaration is carried out by the manufacturer himself. The EAC Declaration becomes legally binding after its registration by a notified body in the EAEU.

The registration of the EAC Declaration may only be carried out by a company established in the territory of the EAEU. Therefore an authorized representative within the EAEU is required. If you need an authorized representative, we will be pleased to offer you a suitable company that takes over this function.

State registration

The conformity assessment of the products listed in Annex 12 occurs in the form of state registration. The state registration acknowledges the conformity assessment of the products with the sanitary-hygienic regulations of the EAEU.

The notified bodies accredited by Rosstandart or Rospotrebnadzor are responsible for issuing certificates of state registration. The registration procedure includes both an analysis of the manufacturer's documents, as well as laboratory tests and, in some cases, an inspection of the production. All certificates of state registration are entered in a special register and kept there.

The products that are subject to state registration:

  • tanning creams
  • products for skin whitening
  • compounds for permanent make-up
  • perfumery and cosmetic products for intimate care
  • cosmetics for children
  • peeling
  • depilatory
  • hair lighteners
  • perfumery and cosmetic products for permanent waves and hair straightening
  • perfumery and cosmetic products with nanoparticles
  • fluorinated oral hygiene products with a mass fraction of fluorides exceeding 0.15%
  • teeth whitening agents containing hydrogen peroxide, carbamide peroxide, zinc peroxide (hydrogen concentration not exceeding 0.1 to 6%)

Process of conformity assessment

Before you can register the EAC Declaration, the products must be tested by an approved laboratory in the EAEU.

The products are tested for the following criteria:

  • composition
  • physical and chemical parameters
  • microbiological parameters
  • content of toxic elements
  • toxic data
  • clinical (clinical-laboratory) measurements
  • processing
  • consumer packaging
  • marking of production

The corresponding requirements and permitted values are specified in the Annexes to the technical regulations 009/2011:

  • Annex 1 contains a list of prohibited substances
  • Annex 2 gives the maximum permissible values for the ingredients in tabular form
  • Annex 3 contains the list of authorized dyes
  • Annex 4 lists the authorized preservatives
  • Annex 5 lists the approved UV filters
  • Annex 6 contains the permitted pH values
  • Annex 7 provides information on microbiological product safety
  • Annex 8 contains requirements for the toxicological indicators

After successful tests, the labs create test reportss. These test reports shall be submitted at the registration of the EAC Declaration in one of the certification body.

Since January 25, 2017, perfumes and cosmetic products can be declared according to 3 schemes:

EAC declaration schemes

Scheme Description
3D is intended for serial production. This scheme requires product samples to be tested by a laboratory accredited by the EAEU.
4D is intended for serial production or a single delivery. This scheme requires product samples to be tested by a laboratory accredited by the EAEU.
6D is intended for serial production. This scheme requires product samples to be tested by a laboratory accredited by the EAEU.

Period of validity of the EAC Declaration

Since January 25, 2017, new provisions have been applied to the validity period of the EAC Declaration.

  1. For series production (Scheme 3d) - 5 years.
  2. For Scheme 4d, the validity period of the EAC declaration is limited to the shelf life of the product.
  3. The declaration according to the scheme 6d is issued for a maximum of 7 years.

EAC marking

TR CU 009/2011 On safety of perfumes and cosmetic products

The products declared according to TR CU 009/2011 must be marked with the EAC conformity mark before launching in the market. The conformity mark shall be affixed to each unit of perfumery and cosmetic production and (or) shipping documents. The marking must be carried out in such a way that it is easily recognizable and legible throughout the entire shelf life of the product. Appropriate marking may only be made if the corresponding production meets the requirements of all relevant technical regulations.

Labeling

The label shall include the following information:

  • product name
  • product indication, e.g. child care products
  • manufacturer, his address
  • country of origin (if the address of the manufacturer does not match the place of manufacture)
  • importer, his address
  • volume
  • color and (or) tone (for make-up)
  • fluorinated oral hygiene products with a mass fraction of fluorides exceeding 0.15%
  • shelf life period and expiration date (month, year) or "durable until: mm-jj" or "use before: mm-jj"
  • instructions for storage
  • information about special precautions
  • delivery number
  • list of ingredients
  • EAC conformity mark

Documents required for the EAC declaration:

  • list of all ingredients
  • copy of documents with details of organoleptic and physico-chemical properties of products
  • test logs (if available)
  • sample of the labeling of the consumer package with the package insert
  • certificate of GMP-compliant quality management system
  • documents which prove the product features announced on the label, e.g. antibacterial effect, light protection factor, anti-wrinkle effect or anti-inflammatory effect of oral hygiene products

Documents required for state registration:

  • list of all ingredients with concentration and mass proportions
  • a quality certificate or a written confirmation from manufacturer that the products meet all quality requirements
  • copy of documents with details of organoleptic and physico-chemical properties of products
  • in the case of the use of nanoparticles, the exact particulars of the chemical composition of the particles and their size must be made
  • a sample of the labeling of the consumer package with the package insert
  • cover sheet with information on consumption characteristics, special precautions for use and instructions for use
  • test reports
  • certificate of GMP-compliant quality management system
  • documents which prove the product features announced on the label, e.g. antibacterial effect, light protection factor, anti-wrinkle effect or anti-inflammatory effect of oral hygiene products.

The supporting documents must be submitted in Russian or in the official language of the Member State of the Customs Union.

Authorized representative

Authorized representativeThe manufacturer, which is not based in one of the member states of the Eurasian Economic Union, is not entitled to request the conformity assessment of cosmetics to comply with the requirements of the relevant technical regulations.

In order to carry out a conformity assessment, the foreign manufacturer must appoint an authorized representative in one of the member states of the Eurasian Economic Union. This then represents the foreign manufacturer's interest in working with the certification bodies of the Eurasian Economic Union with regard to the safety and quality of products and compliance with technical regulations.

According to applicable law and in accordance with the technical regulation of the Economic Union, only an entrepreneur based in the territory of the Eurasian Economic Union may be named as an authorized representative.

Period of validity of EAC conformity assessment certificates for cosmetics

The validity period of the EAC certificate or EAC declaration for cosmetics differs depending on the applied technical regulations, the selected scheme, the type of production (serial production, individual delivery, etc.) and equipment and ranges on average from one to 5 years. Those parameters are determined in the respective technical regulation.

Detailed information on the period of validity of EAC conformity assessment certificates can be found here.

Duration and costs for EAC certification

The duration and costs associated with an EAC certificate application for cosmetics depend on several different factors, such as the classification of the product, any required laboratory checks and the complexity of all examinations. As such the exact conditions of the EAC certification are always determined individually based on the required documentation.
Please note that an application for an EAC certificate can take several weeks to process.

Detailed information on the duration and costs of EAC conformity assessment certificates can be found here.

Delivery of the documentation

If you order the EAC Certificate on cosmetics, you will receive a copy of it via email immediately after our successful certification procedure. The original document and two certified copies will be sent by post.

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contact@schmidt-export.com